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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Invented name:||Busulfan Fresenius Kabi This product is authorised under a different brand name in the EU in the following languages: - Бусулфан Fresenius Kabi (BG) - Busulfano Fresenius Kabi (ES) - BUSULFAN FRESENIUS KABI (FR) - Bussulfano Fresenius Kabi (PT)|
|Auth. number :||EU/1/14/951|
|Active substance :||busulfan|
|ATC:||Anatomical main group: L - Antineoplastic and immunomodulating agents|
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01A - Alkylating agents
Chemical subgroup: L01AB - Alkyl sulphonates
Chemical substance: L01AB01 - busulfan
(See WHO ATC Index)
|Indication:||Busulfan followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to|
conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the
combination is considered the best available option.
Busulfan following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic
progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity
conditioning (RIC) regimen.
Busulfan followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning
treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
|Marketing Authorisation Holder:||Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom
|EPAR and active package presentations|
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".|
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|24/09/2014||Centralised - Authorisation||EMEA/H/C/2806||(2014)6865 of 22/09/2014|
|13/03/2015||Centralised - 2-Monthly update||EMEA/H/C/2806/IB/1||(2015)1744 of 11/03/2015|
|19/10/2017||Centralised - Variation||EMEA/H/C/2806/IB/3/G|
|21/12/2017||Centralised - Variation||EMEA/H/C/2806/IB/6|